BCR-ABL1 Standard p210, p190
Also known as: Philadelphia chromosome, BCR-ABL1 Major, BCR-ABL1 Minor, BCR/ABL1 Standard
Use
This assay is intended for use as an aid in the diagnosis and management of BCR-ABL1 (p210) positive and/or BCR-ABL1 (p190) positive chronic myelogenous leukemia (CML), acute lymphoblastic leukemia (ALL), and other leukemic patients with Philadelphia chromosome, including those undergoing kinase inhibitor therapy (e.g. imatinib, nilotinib, dasatinib). This test may be used to monitor efficacy of therapy or minimal residual disease (MRD) and is not recommended as a sole primary diagnostic test for CML or other acute leukemia. The trend of these results over time is more informative of disease status than an individual result.
Special Instructions
Not provided.
Limitations
Analytical sensitivity is 0.002% for p210 and 0.005% for p190, depending on quality and quantity of the isolated RNA and absence of interfering substances. Log reduction score and percent abnormal are reported, and longitudinal data will appear as a NeoTRACK Result on the report.
New York Approved
Methodology
PCR-based (RT-PCR)
Biomarkers
BCR-ABL1 fusion
Fusion
Result Turnaround Time
5 days
Related Documents
For more information, please review the documents below
Specimen
Bone Marrow
Volume
2 mL
Minimum Volume
Not provided
Container
EDTA tube
Storage Instructions
Use cold pack for transport, making sure cold pack is not in direct contact with specimen.